In the past, excipients used in China were regulated in the same manner as drugs or active pharmaceutical ingredients (APIs).
The domestic implementation of licensing requirements was somewhat inconsistent for excipients, however. SFDA proposes to
separate the regulation of excipients to facilitate improved control of quality for both domestic and imported excipients.
The goals of their proposed excipient regulations are to improve the quality of excipients, minimize safety risks, and to
align SFDA regulations with international standards. In developing the excipient regulations, SFDA has proposed to use the
basic principles of its drug regulations as a foundation for excipient regulation. The proposed regulations, however, do not
recognize the significant differences between excipients, APIs, and drug products in terms of typical international regulatory
The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas), a trade association of manufacturers
of excipients and drug products, has led an industry coalition representing excipient producers and users that works with
SFDA to clarify the requirements for obtaining a Chinese import license and to assist SFDA in achieving its goal of improved
excipient quality and safety. IPEC-Americas representatives have attended meetings with SFDA to discuss the differences between
excipient regulations in the US, Europe, and Japan and the proposed excipient regulations in China. A coalition coordinated
by the International Pharmaceutical Excipients Council (IPEC) has requested several changes to the proposed regulations to
achieve better harmonization with international standards and requirements. The IPEC Coalition includes IPEC Americas, IPEC
Europe, and the Japanese Pharmaceutical Excipients Council (JPEC).
Status of proposed licensing regulation
The IPEC Coalition, in collaboration with the US Department of Commerce, presented the industry's concerns to SFDA at a meeting
of the Joint Commission on Commerce and Trade (JCCT) in March 2006. This discussion, along with several follow-up meetings
in April 2006, resulted in a fairly favorable first step toward improved excipient regulation. The IPEC Coalition and other
participants provided SFDA with information about the regulation of excipients in the US, Europe, and Japan and identified
problem areas in SFDA's proposed regulations that would significantly affect both excipient manufacturers seeking import licenses
and pharmaceutical companies who would use these materials in China.
SFDA informed the participants that, unlike in most developed countries where pharmaceutical manufacturers essentially regulate
their use of excipients with limited regulatory agency oversight, China's government must be responsible for excipient quality.
SFDA believes that many Chinese pharmaceutical manufacturers do not have good systems in place to properly qualify excipient
suppliers and control excipient quality. SFDA believes that the government must step in to provide adequate protection to
Chinese consumers. Accomplishing this goal may require some type of excipient licensing system, according to the agency.
On the other hand, SFDA wants to draft regulations based on appropriate international standards and does not want to impose
unrealistic regulations on imported excipients. The agency expects to be able to review the same type of information used
to establish excipient quality and safety that is required by international regulatory authorities during the drug-registration
process. Since most regulators outside China do not require significant detailed information to be submitted for compendial
excipients, SFDA may relax its proposed license requirements for these types of materials.
SFDA and the Coaltion agreed that detailed safety and manufacturing information should be required for the licensing of new
excipients and that the regulations should reflect the different needs for evaluating compendial excipients versus new excipients.
SFDA stated that it will study the excipient GMPs and other guidelines provided by the IPEC Coalition to further revise its
excipient regulations. SFDA expressed a desire to learn from other countries' success and to use that experience to develop
excipient regulations for China. SFDA also noted that although the new excipient regulations have been proposed, no firm implementation
date had been set, and that it was unlikely that they will be finalized until 2008. SFDA will use the time to carefully review
and assess the documents supplied to them, as well as the various presentations made during its meetings with IPEC Coalition
One outcome of the 2006 meetings was the recognition of the need to hold an excipient conference in China to discuss how excipients
are regulated globally. Such a conference would facilitate SFDA's collaboration with industry for a mutually beneficial resolution
of the licensing requirements. In 2007, the IPEC Coalition has continued to help SFDA develop excipient regulations that are
science-based and achievable without causing undue regulatory burden that may result in some excipient manufacturers exiting